Clinical trials are safe, but you can make them safer

You may have seen the news that a clinical trial participant in France has died and that 4 others were hospitalised. This is obviously a terrible event, our understanding is it was unexpected and authorities are working to determine if there was any wrongdoing.

The question on many of our patient’s minds may be was this an isolated event or are clinical trials inherently unsafe?

The answer is a bit of both.

Events such as what happened in France are rare. Such an event had never before happened in France and worldwide the last similar incident was 9 years ago.

However the study in question was what is known as a phase 1 trial. Phase 1 trials are done to assess the safety of a new medication and include the first use of a medication in humans. As such there is always a risk that a serious, unexpected reaction may occur. Pharmaceutical companies work hard to determine the safety of medications, prior to testing on humans and follow protocols to minimise this risk.

Our clinical trials

The Keogh Institute does not conduct phase 1 trials.

We conduct only phase 2, 3 and 4 studies where safety of the medication has been established. The purpose of our clinical trials is primarily to determine effectiveness. Participants in these studies are monitored by a variety of procedures throughout the study to ensure the safety and effectiveness of the drug. If there is any sign that the taking the medication is no longer in the interest of the participant, the medication is discontinued immediately or as soon as safe to do so.

We follow strict procedures to ensure your safety. However, all medications have a risk of a side effect so taking any medication carries some element of risk. Personal aspects of your health may also increase the risk of side effects occuring during the study.

Steps you can take to ensure your safety.

Read the Patient Information and Consent Form (PICF): Every known or predicted side effect is listed in the PICF alongside the probability of it occurring. Take the time to read it thoroughly and consider the information in the form. Discuss the form with anyone who has an investment in your health, including your GP or specialist.

Ask questions: If you are concerned about anything that you read in the PICF, ask the study coordinator or a study doctor about it. You should not take part in the study if anything about the study is still concerning to you.

Be honest: We can only assess whether you are safe to continue in the study if we understand everything about you. This is why we ask about your medical history and other medications that you are taking. Make sure you tell us everything, including if you are taking vitamins or herbal products.

Once you are on the study, you should continue to tell us of any symptoms you have experienced in between your visits and any changes in your medication. This allows us to continue to determine if it is safe for you to continue on the study.

Be compliant: When you are on study we will ask you to come to see us at set times, undergo procedures including blood tests and take your medication as instructed. We may even ask you to abstain from particular activity, including drinking or sexual activity. Often we are asking you to do this for the sake of your safety. If you need to change something, contact us and we will instruct you on what is safe to do.

If we detect a change that may affect your safety, we may ask you to come back in and see us. Please do so. Most of the time it will be a false alarm, but it is best to be safe.

Talk to us: If you experiencing a side effect you think is related to the study medication you should talk to us about it. Even if you decide you no longer wish to take the medication, you should come in and see us. There may be procedures to follow to ensure the safe discontinuation of the medication or we may need to do further follow up on your side effect. We can limit these investigations to those needed for your safety.

Your safety is important to us but the most important protector of your safety is you. In order for us to ensure your safety and the safety of others who may take the medication in the future, we need you to help us.